Nasal and Oral Inhalers and AQ
Nasal Spray: Triamcinolone acetonide, USP, Nasal Inhaler,
is a glucocorticosteroid with a molecular weight of 434.51 and with
the chemical designation
9-Fluoro-11b, 16a,
17,21-tetrahydroxypregna-1, 4-diene-3,20-dione cyclic 16,17-acetal
with acetone. (C24H31FO6).

Oral Inhaler: Triamcinolone acetonide Oral Inhaler
is a metered-dose aerosol
unit containing a microcrystalline
suspension of triamcinolone
acetonide in the propellant dichlorodifluoromethane and dehydrated
alcohol USP 1% w/w. Each canister contains 60 mg
triamcinolone
acetonide. Each actuation releases approximately 200 mcg
triamcinolone
acetonide, of which approximately 100 mcg
are delivered from the unit
(in vitro testing). There are at least 240 actuations in
one triamcinolone
acetonide aerosol canister. After 240 actuations, the amount delivered
per actuation may not be
consistent and the unit
should be discarded.

AQ Nasal Spray: Triamcinolone Acetonide AQ
Nasal Spray is an unscented, thixotropic, water-based metered-dose
pump spray formulation
unit containing a microcrystalline
suspension of triamconolone
acetonide in an aqueous
medium. Microcrystalline cellulose, carboxymethylcellulose sodium,
polysorbate 80, dextrose, benzalkonium chloride, and edetate disodium
are contained in this aqueous
medium; hydrochloric acid
or sodium hydroxide may
be added to adjust the pH
to a target of 5.0 within
a range of 4.5 and 6.0.

Each bottle contains 9.075 mg
triamcinolone
acetonide. Each actuation delivers 55 mcg
triamcinolone
acetonide from the nasal
actuator to the patient
(estimated from in vitro testing) after an initial
priming of 5 sprays. It will
remain adequately primed for 2 weeks. If the product is not used
for more than 2 weeks, then it can be adequately reprimed with one
spray. There are at least 120 actuations in one triamcinolone
acetonide AQ nasal spray
bottle. After 120 actuations, the amount of triamcinolone acetonide
delivered per actuation
may not be consistent and the unit
should be discarded. In
the manufacturer's original package insert, patients are provided
with a check-off form to
track usage in the Information for Patients tear-off sheet.

Nasal Inhaler: Triamcinolone acetonide Nasal Inhaler
is a metered-dose aerosol
unit containing a microcrystalline
suspension of triamcinolone
acetonide in dichlorodifluoromethane and dehydrated alcohol USP
0.7% w/w. Each canister contains 15 mg
triamcinolone
acetonide. Each actuation releases approximately 55 mcg
triamcinolone
acetonide from the nasal actuator
to the patient (estimated
from in vitro testing). There are at least 100 actuations
in one triamcinolone
acetonide Nasal Inhaler canister. After 100 actuations, the amount
delivered per actuation
may not be consistent and the unit
should be discarded. Patients are provided with a check-off
card to track usage as party
of the Information for Patients tear-off sheet.

Triamcinolone acetonide (sterile triamcinolone
acetonide suspension, USP) provides triamcinolone
acetonide, a synthetic
corticosteroid
with marked anti-inflammatory action, in a sterile
aqueous suspension
suitable for intradermal, intra-articular, and intrabursal injection
into tendon sheaths. The preparation
is NOT suitable for IV or
IM use. Each ml of the sterile
aqueous suspension
provides 10 mg triamcinolone
acetonide, with sodium chloride
for isotonicity, 0.9% (w/v) benzyl
alcohol as preservative,
0.75% carboxymethylcellulose sodium, and 0.04%, polysorbate 80;
sodium hydroxide or hydrochloric may have been added to adjust pH
between 5.0 and 7.5. At the
time of manufacture, the
air in the container
is replaced by nitrogen. The chemical
name is 9-fluoro- 11b,16a,17,21-tetrahyroxypregna-1,4-diene
-3,20- dione cyclic 16,17-
acetal with- acetone.

Injection-40: (Not for IV
or Intradermal Use).

Triamcinolone acetonide (sterile triamcinolone
acetonide suspension, USP) provides triamcinolone
acetonide, a synthetic
corticosteroid
with marked anti-inflammatory action. Each ml
of the sterile aqueous
suspension provides 40 mg
triamcinolone
acetonide, with sodium
chloride for isotonicity,
0.9% (w/v) benzyl alcohol
as preservative, 0.75% carboxymethylcellulose sodium, and 0.04%,
polysorbate 80. Sodium hydroxide
or hydrochloric may have been added to adjust pH
between 5.0 and 7.5. At the
time of manufacture, the
air in the container
is replaced by nitrogen.

Aerosol Spray, Cream, and Ointment: (For Dermatologic
Use Only)

The topical corticosteroids
constitute a class of
primarily synthetic steroids used as anti-inflammatory and antipruritic
agents. The steroids in the class
include triamcinolone
acetonide. The chemical
name is 9- Fluoro-11b,16b,17,
21- tetrahyroxypregna-1,4-diene-3,20-dione cyclic
16,17-acetal with acetone.

Aerosol Spray: A two-second application which covers
an area approximately the size of the hand, delivers an amount of
triamcinolone acetonide not exceeding 0.2. After spraying, the nonvolatile
vehicle remaining on
the skin contains approximately
0.2% triamcinolone
acetonide. Each gram of spray provides 0.147 mg
triamcinolone
acetonide in a vehicle
of isopropyl palmitate, dehydrated alcohol
(10.3%) and isobutane propellant.